Dyslipidemia, Hypercholesterolemia, High Cholesterol
Conditions
Keywords
obicetrapib, statin, LDL-C cholestero, l atherosclerosis
Brief summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up visit.
Interventions
DRUGObicetrapib
tablet
DRUGPlacebo
No active ingredient
Sponsors
NewAmsterdam Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo tablet made to resemble active product
Intervention model description
Placebo-controlled, double-blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* LDL-C \> 70 mg/dL and TG \< 400 mg/dL, * Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20
Exclusion criteria
* BMI \> or =35 kg/m2 * Significant cardiovascular disease * HbA1c \> 10% * Uncontrolled hypertension * Active muscle disease * GFR \< 60 ml/min * Hepatic dysfunction * Anemia * Existing CETP deficiency * History of Homozygous Familial Hypercholerstrolemia * History of malignancy * Alcohol abuse * Treatment with investigational product * Treatment with PCSK9 * Clinically significant condition * Known CETP inhibitor allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8 Weeks | Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC). |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8 Weeks | Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC). |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8 Weeks | LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC). |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8 Weeks | Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8 Weeks | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC) |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8 Weeks | Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8 weeks | Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| Mean Percent Change in Apolipoprotein B (ApoB) | 8 Weeks | Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8 Weeks | LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8 Weeks | Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| Median Percent Change in Apolipoprotein B (ApoB) | 8 Weeks | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| LS Mean Percent Change in Apolipoprotein B (ApoB) | 8 Weeks | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8 weeks | Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8 Weeks | Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8 Weeks | LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Once-daily placebo
Obicetrapib: No active ingredient | 26 |
| 2.5 mg Obicetrapib once-daily Obicetrapib
Obicetrapib: tablet | 25 |
| 5 mg Obicetrapib once-daily Obicetrapib
Obicetrapib: tablet | 25 |
| 10 mg Obicetrapib once-daily Obicetrapib
Obicetrapib: tablet | 26 |
| Total | 102 |
Baseline characteristics
| Characteristic | Placebo | 2.5 mg Obicetrapib | 5 mg Obicetrapib | 10 mg Obicetrapib | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 9.44 | 65.8 years STANDARD_DEVIATION 8.09 | 67.8 years STANDARD_DEVIATION 9.46 | 62.5 years STANDARD_DEVIATION 9.9 | 64.8 years STANDARD_DEVIATION 9.36 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values | 110.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 37.13 | 102.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 26.58 | 106.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.54 | 109.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 32.47 | 106.95 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 25 Participants | 25 Participants | 26 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 25 Participants | 25 Participants | 26 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 6 Participants | 7 Participants | 29 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 19 Participants | 19 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 15 / 26 | 9 / 25 | 7 / 25 | 15 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 1 / 25 | 0 / 26 |
Outcome results
Primary
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -0.48 percent change from baseline | Standard Error 3.766 |
| 2.5 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -26.32 percent change from baseline | Standard Error 3.844 |
| 5 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -33.82 percent change from baseline | Standard Error 3.838 |
| 10 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -36.60 percent change from baseline | Standard Error 3.765 |
p-value: <0.000195% CI: [-36.53, -15.14]Mixed Models Analysis
p-value: <0.000195% CI: [-44.01, -22.66]Mixed Models Analysis
p-value: <0.000195% CI: [-46.68, -25.55]Mixed Models Analysis
Primary
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 0.69 percent change from baseline | Standard Error 3.928 |
| 2.5 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -26.51 percent change from baseline | Standard Error 4.013 |
| 5 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -30.54 percent change from baseline | Standard Error 4.002 |
| 10 mg Obicetrapib | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -36.12 percent change from baseline | Standard Error 3.926 |
p-value: <0.000195% CI: [-38.37, -16.04]ANCOVA
p-value: <0.000195% CI: [-42.36, -20.1]ANCOVA
p-value: <0.000195% CI: [-47.83, -25.8]ANCOVA
Primary
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -0.78 percent change from baseline | Standard Deviation 14.581 |
| 2.5 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -25.90 percent change from baseline | Standard Deviation 21.259 |
| 5 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -33.78 percent change from baseline | Standard Deviation 13.247 |
| 10 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -36.80 percent change from baseline | Standard Deviation 25.727 |
p-value: <0.000195% CI: [-36.53, -15.14]Mixed Models Analysis
p-value: <0.000195% CI: [-44.01, -22.66]Mixed Models Analysis
p-value: <0.000195% CI: [-46.68, -25.55]Mixed Models Analysis
Primary
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 0.43 percent change from baseline | Standard Deviation 15.456 |
| 2.5 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -26.10 percent change from baseline | Standard Deviation 23.477 |
| 5 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -30.50 percent change from baseline | Standard Deviation 14.959 |
| 10 mg Obicetrapib | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -36.29 percent change from baseline | Standard Deviation 24.513 |
p-value: <0.000195% CI: [-38.37, -16.04]ANCOVA
p-value: <0.000195% CI: [-42.36, -20.1]ANCOVA
p-value: <0.000195% CI: [-47.83, -25.8]ANCOVA
Primary
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -0.89 percent change from baseline |
| 2.5 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -24.81 percent change from baseline |
| 5 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -31.94 percent change from baseline |
| 10 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -45.80 percent change from baseline |
Comparison: p value is calculatedp-value: <0.000195% CI: [-36.53, -15.14]Mixed Models Analysis
p-value: <0.000195% CI: [-44.01, -22.66]Mixed Models Analysis
p-value: <0.000195% CI: [-46.68, -25.55]Mixed Models Analysis
Primary
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 0.67 percent change from baseline |
| 2.5 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -25.97 percent change from baseline |
| 5 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -30.40 percent change from baseline |
| 10 mg Obicetrapib | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -43.72 percent change from baseline |
p-value: <0.000195% CI: [-38.37, -16.04]ANCOVA
p-value: <0.000195% CI: [-42.36, -20.1]ANCOVA
p-value: <0.000195% CI: [-47.83, -25.8]ANCOVA
Secondary
LS Mean Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Apolipoprotein B (ApoB) | -1.42 percent change from baseline | Standard Error 2.407 |
| 2.5 mg Obicetrapib | LS Mean Percent Change in Apolipoprotein B (ApoB) | -20.43 percent change from baseline | Standard Error 2.457 |
| 5 mg Obicetrapib | LS Mean Percent Change in Apolipoprotein B (ApoB) | -23.87 percent change from baseline | Standard Error 2.457 |
| 10 mg Obicetrapib | LS Mean Percent Change in Apolipoprotein B (ApoB) | -26.29 percent change from baseline | Standard Error 2.408 |
p-value: <0.000195% CI: [-25.83, -12.18]Mixed Models Analysis
p-value: <0.000195% CI: [-29.28, -15.62]Mixed Models Analysis
p-value: <0.000195% CI: [-31.62, -18.1]Mixed Models Analysis
Secondary
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 3.90 percent change from baseline | Standard Error 7.141 |
| 2.5 mg Obicetrapib | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 137.00 percent change from baseline | Standard Error 7.284 |
| 5 mg Obicetrapib | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 151.30 percent change from baseline | Standard Error 7.282 |
| 10 mg Obicetrapib | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 159.87 percent change from baseline | Standard Error 7.139 |
p-value: <0.000195% CI: [112.85, 153.36]Mixed Models Analysis
p-value: <0.000195% CI: [127.17, 167.64]Mixed Models Analysis
p-value: <0.000195% CI: [135.93, 176.02]Mixed Models Analysis
Secondary
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -1.72 percent change from baseline | Standard Error 3.395 |
| 2.5 mg Obicetrapib | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -25.66 percent change from baseline | Standard Error 3.463 |
| 5 mg Obicetrapib | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -30.11 percent change from baseline | Standard Error 3.463 |
| 10 mg Obicetrapib | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -30.28 percent change from baseline | Standard Error 3.395 |
p-value: <0.000195% CI: [-33.56, -14.31]Mixed Models Analysis
p-value: <0.000195% CI: [-38.01, -18.76]Mixed Models Analysis
p-value: <0.000195% CI: [-38.08, -19.03]Mixed Models Analysis
Secondary
Mean Percent Change in Apolipoprotein B (ApoB)
Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change in Apolipoprotein B (ApoB) | -1.23 percent change from baseline | Standard Deviation 10.614 |
| 2.5 mg Obicetrapib | Mean Percent Change in Apolipoprotein B (ApoB) | -19.80 percent change from baseline | Standard Deviation 15.363 |
| 5 mg Obicetrapib | Mean Percent Change in Apolipoprotein B (ApoB) | -24.48 percent change from baseline | Standard Deviation 13.909 |
| 10 mg Obicetrapib | Mean Percent Change in Apolipoprotein B (ApoB) | -26.66 percent change from baseline | Standard Deviation 15 |
p-value: <0.000195% CI: [-25.83, -12.18]Mixed Models Analysis
p-value: <0.000195% CI: [-29.28, -15.62]Mixed Models Analysis
p-value: <0.000195% CI: [-31.62, -18.1]Mixed Models Analysis
Secondary
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 5.57 percent change from baseline | Standard Deviation 13.271 |
| 2.5 mg Obicetrapib | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 134.75 percent change from baseline | Standard Deviation 56.543 |
| 5 mg Obicetrapib | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 153.16 percent change from baseline | Standard Deviation 46.879 |
| 10 mg Obicetrapib | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 158.75 percent change from baseline | Standard Deviation 43.171 |
p-value: <0.000195% CI: [112.85, 153.36]Mixed Models Analysis
p-value: <0.000195% CI: [127.17, 167.64]Mixed Models Analysis
p-value: <0.000195% CI: [135.93, 176.02]Mixed Models Analysis
Secondary
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -1.80 percent change from baseline | Standard Deviation 12.328 |
| 2.5 mg Obicetrapib | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -25.42 percent change from baseline | Standard Deviation 19.28 |
| 5 mg Obicetrapib | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -30.38 percent change from baseline | Standard Deviation 13.839 |
| 10 mg Obicetrapib | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -30.25 percent change from baseline | Standard Deviation 23.318 |
p-value: <0.000195% CI: [-33.56, -14.31]Mixed Models Analysis
p-value: <0.000195% CI: [-38.01, -18.76]Mixed Models Analysis
p-value: <0.000195% CI: [-38.08, -19.03]Mixed Models Analysis
Secondary
Median Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Percent Change in Apolipoprotein B (ApoB) | -0.36 percent change from baseline |
| 2.5 mg Obicetrapib | Median Percent Change in Apolipoprotein B (ApoB) | -22.50 percent change from baseline |
| 5 mg Obicetrapib | Median Percent Change in Apolipoprotein B (ApoB) | -21.43 percent change from baseline |
| 10 mg Obicetrapib | Median Percent Change in Apolipoprotein B (ApoB) | -29.67 percent change from baseline |
p-value: <0.000195% CI: [-25.83, -12.18]Mixed Models Analysis
p-value: <0.000195% CI: [-29.28, -15.62]Mixed Models Analysis
p-value: <0.000195% CI: [-31.62, -18.1]Mixed Models Analysis
Secondary
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 5.22 percent change from baseline |
| 2.5 mg Obicetrapib | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 114.29 percent change from baseline |
| 5 mg Obicetrapib | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 144.44 percent change from baseline |
| 10 mg Obicetrapib | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 158.90 percent change from baseline |
p-value: <0.000195% CI: [112.85, 153.36]Mixed Models Analysis
p-value: <0.000195% CI: [127.17, 167.64]Mixed Models Analysis
p-value: <0.000195% CI: [135.93, 176.02]Mixed Models Analysis
Secondary
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
Population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -0.37 percent change from baseline |
| 2.5 mg Obicetrapib | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -23.74 percent change from baseline |
| 5 mg Obicetrapib | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -29.82 percent change from baseline |
| 10 mg Obicetrapib | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -36.96 percent change from baseline |
p-value: <0.000195% CI: [-33.56, -14.31]Mixed Models Analysis
p-value: <0.000195% CI: [-38.01, -18.76]Mixed Models Analysis
p-value: <0.000195% CI: [-38.08, -19.03]Mixed Models Analysis